The educational materials for patients or educational materials for healthcare professionals included here are additional risk minimisation measures that are intended to promote the safe and effective use of the medicinal product. Risk minimisation measures are a regulatory requirement and are part of the RMP (Risk Management Plans) approved by the EMA. They are assessed at national level by the HPRA for approval in Ireland.
Beovu Patient Therapy Guide Booklet v8.1; Beovu Patient Therapy Guide Audio CD v8.1 (HPRA approved August 2022)
Erelzi Patient Card v5.1 (HPRA approved October 2021)
Exelon Diary v6.3 (HPRA approved August 2021)
Physicians Checklist v20.1; HCP Brochure v20.1; Patient Handbook v20.1 (HPRA approved March 2023)
Gilenya RMP reminder card v18.0; Gilenya pregnancy reminder card v18.0; Gilenya prescriber's checklist v18.0 (HPRA approved October 2022)
Adult Patient Card v3.1; Paediatric Patient Card v3.1 (HPRA approved April 2022)
Lucentis Patient Booklet PDR and/or DME v20 and Lucentis Patient Guide PDR and/or DME Audio CD v20 (HPRA approved April 2020); Lucentis Patient Guide to AMD v16; Lucentis Patient Guide to CNV v16 and Lucentis Patient Guide to RVO v16 (HPRA approved March 2017)
Guide for HCPs v2.1; Guide for Patients v2.1 (HPRA approved October 2018)
Reporting of side effects
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance, website www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.